Apricus Biosciences Announces Corporate Goals for 2013
Company to Focus Its Corporate Strategy on Vitaros(R) and Femprox(R) and Will Seek Strategic Alternatives for Its Oncology Supportive Care Business
SAN DIEGO, Jan. 3, 2013 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (www.apricusbio.com) today announced its corporate goals for 2013, which includes focusing its corporate strategy on its high value assets such as Vitaros® for erectile dysfunction ("ED") and Femprox® for female sexual arousal disorder ("FSAD") and plans to seek a buyer for its oncology supportive care products, which consists of two approved products now sold in the United States. The planned divestiture will allow Apricus Bio to better align its resources with its main corporate objectives.
Rusty Ray, Chairman of the Board of Apricus Bio, commented, "The Board of Directors believes that the greatest potential for shareholder value creation is in the further development and commercialization, through strategic partnerships, of the Company's primary commercial and pipeline assets, particularly Vitaros® (alprostadil 0.3% topical cream) and Femprox® (alprostadil 0.4% topical cream) for male and female sexual health. Both products utilize Apricus Bio's proprietary NexACT® transdermal delivery platform. The Company's resources therefore, will be directed toward these key assets, a decision that will concentrate the Company's strategic focus and better allow us to deliver value through 2013 and beyond."
Apricus Bio's oncology supportive care business includes the rights to Totect® (dexrazoxane for injection) for the treatment for extravasation from intravenous anthracycline chemotherapy in the U.S. and the Americas, and the U.S. co-promotion rights to Granisol® (granisetron HCl oral solution) for the prevention of nausea and vomiting associated with certain emetogenic cancer therapy and radiation in the US. Each of these products is now commercially available and marketed in the U.S.
"We achieved important progress with respect to Apricus Bio's pipeline development and commercialization goals in 2012, including, manufacturing, preparation and assistance in Abbott Laboratories' up-coming launch of Vitaros® in Canada and the steps of responding and advancing Vitaros® through what is hopefully European approval in 2013," said Steve Martin, Interim Chief Executive Officer and Chief Financial Officer of Apricus Bio. "These steps will position us to build significant value for our shareholders as we execute our strategy over the coming year."
Vitaros®, Apricus Bio's lead product candidate for the treatment of ED, is a topically-applied cream formulation of alprostadil, a vasodilator, which directly increases blood flow to the penis, causing an erection. Alprostadil is a widely accepted alternative to the PDE5 inhibitors for difficult to treat patients, and Vitaros® is relatively safe and effective, and offers greater market opportunity due to its patient-friendly form versus both other alprostadil dosage forms and also relative to oral ED products. With a market affecting nearly 150 million men worldwide and representing approximately $2.6 billion in revenue – excluding the U.S. – Vitaros® represents a major market opportunity, particularly as a distinct product that addresses a significant underserved population. Vitaros®-related goals for 2013 include:
- Commercial launch in Canada through Abbott Laboratories. Apricus Bio is actively supporting Abbott with their pre-launch efforts, and continues to expect that a full launch will occur in the first half of 2013.
- European approval via the Decentralized Procedure ("DCP"). A decision regarding the approval of Vitaros® in Europe via the DCP with Netherlands as the Reference Member State is expected to occur in the first half of 2013, followed by national phase approvals in each of the major markets of Europe. Marketing of Vitaros® can then be initiated in each country either by Apricus Bio partners or by the Company directly as applicable. In Europe, existing ED products currently generate over $1 billion dollar in sales and Apricus Bio believes a significant portion of the market remains untreated or undertreated.
- Secure additional partnerships.Vitaros® is now partnered in key markets around the world, including the U.S., Canada, Germany, the United Kingdom, Italy, the Gulf countries, certain other countries in the Middle East and Israel. In France, a very significant ED market, Apricus Bio is preparing to commercialize the product directly through its European sales subsidiary. The Company is looking to secure partnerships in the remaining international territories, particularly in the emerging markets.
Femprox® is a topical alprostadil cream for the treatment of FSAD. In recent months, Apricus Bio completed pre-filing meetings with Health Canada and the U.S. FDA regarding the suitability of its existing clinical, preclinical, and chemistry data for Femprox® to support filings in each country. Femprox®-related goals for 2013 include:
- Obtain feedback from regulatory agencies and initiate next clinical steps. In 2013, Apricus Bio expects to announce feedback from its meeting with Health Canada and the U.S. FDA, as well as its plan for Femprox® clinical development going forward.
Oncology Supportive Care
The Company intends to seek a buyer for its U.S. oncology supportive care business, which is being conducted through Apricus Pharmaceuticals USA, Inc., its wholly-owned subsidiary ("Apricus Pharma"). Apricus Pharma has been focused on commercializing its oncology supportive care products, including Totect® and Granisol® in the U.S. In connection with the proposed sale and divestiture of this subsidiary and/or its products, the Company expects to terminate certain employees and all of the members if its U.S. contract sales force that are associated with Apricus Pharma.
As a result of this strategic action, the Company expects to incur one-time costs of approximately $0.3 million in connection with the workforce reduction. Asset balances related to the Apricus Pharma segment as of December 31, 2012, total approximately $5.5 million, which consist of intangible assets and goodwill of $4.7 million and inventory and other assets of $0.8 million. Any possible impairment charge associated with the potential sale of the business cannot yet be determined. The restructuring and divestiture will have the effect of reducing the use of cash for this business segment in 2013 and proceeds from any potential sale of the assets in the future would supplement our cash resources. As of December 31, 2012, Apricus Bio has cash and cash equivalents of approximately $15.0 million.
Additional details regarding the potential sale of the business are set forth in the Company's Form 8-K filed today.
About Vitaros® and the Canadian ED Market
According to IMS Health data, the annual ED market in Canada in 2010 was approximately $180 million (CAD). The current leading medications are sildenafil citrate, tadalafil and vardenafil HCI which are taken in pill form and work by inhibiting an enzyme called PDE5.
There is still a need for new, safe and effective treatments, however, especially for those patients who cannot or do not respond well to oral medications. Vitaros® is applied topically which helps to reduce side effects and offers men who do not do well with the existing oral drugs a patient-friendly alternative. When absorbed through the skin, Vitaros® directly boosts blood flow, thereby causing an erection within minutes -- much faster than the results achieved from the oral medications.
The key innovation behind Vitaros® was combining alprostadil with Apricus Bio's NexACT® drug delivery technology. The NexACT® technology allows the drug to pass through the skin and makes the treatment much easier to apply and provides patients with a relatively safer alternative treatment because it avoids certain complications that can be associated with oral products.
In clinical studies, Vitaros® showed efficacy in patients suffering from mild to severe ED, including men who did not respond to sildenafil citrate. The side effects reported were localized and transient.
Femprox® is a product candidate for the treatment of FSAD. Nine clinical studies have been successfully completed to date, including one, 98-subject Phase II study in the US and a nearly 400-subject Phase III study in China. To date, no product has been approved to treat FSAD, a persistent or recurring inability to attain or maintain adequate sexual excitement, causing personal distress. Estimates of the FSAD market size put it on par with ED in males.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. is a pharmaceutical company that develops and markets innovative treatments that help large patient populations across numerous, large-market therapeutic classes including male and female sexual health. Apricus Bio is headquartered in San Diego, California and is publicly traded on the NASDAQ Capital Market under the ticker symbol APRI.
For further information on Apricus Bio, visit http://www.apricusbio.com, and for information on its subsidiary please visit http://www.nexmedusa.com. You can also receive information at http://twitter.com/apricusbio.
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to: its ability to sell its oncology supportive care business on reasonable economic terms and not incur significant impairment charges, its ability to achieve its development, commercialization and financial goals, its ability to further develop its products and product candidates, the timing for the commercial launch of Vitaros® in Canada, and its ability to have its products and product candidates approved by relevant regulatory authorities, including in Europe. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.
CONTACT: Apricus Bio Investor Relations: David Pitts Argot Partners 212-600-1902 email@example.com